FDA UDI
In Commercial Distribution
🇺🇸 United States
NAMIC
DI: 10197344043200
·
Model: 60020209A
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- NAMIC
- Primary DI
- 10197344043200
- Version / Model
- 60020209A
- Catalog Number
- 60020209A
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-28
- Public Version
- 1
- Public Version Date
- 2024-03-07
- Public Version Status
- New
- Public Device Record Key
- 0ddfa47b-3472-47a1-ac8f-39a234b66d97
Device Description
MSC US CORONARY KIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OEZ | Cardiovascular procedure kit | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16545 | Angiography kit | A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20197344043207 | GS1 | Box | 8 | In Commercial Distribution | |
| Primary | 10197344043200 | GS1 | ||||
| Package | 30197344043204 | GS1 | Case | 16 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]